| Eligibility |
- Willingness to maintain current lifestyle (diet and exercise) practices (other than
avoiding or limiting alcohol)
- Willing to avoid alcohol during the study OR limit alcohol consumption to 1-2 glasses
of light beer or wine for the 1-2 days after the stool collection for visits 2, 3 and
4 (Participants who choose to consume alcohol will be given List of Foods A and
Participant Checklist A while others will be given the B versions)
- Willingness to give informed consent to participate in the study.
- Presence of minor symptoms of bloating or constipation or irregular bowel movements
- Willingness and ability to collect per the two stool test kit procedures 10 stool
samples at home and ship per instructions
- Willing to have blood drawn 3 times (not applicable to those impacted by circumstances
associated with COVID-19 pandemic)
- Ability to speak, read and understand English
- Ability to participate via telemedicine (phone or video calls for study visits and
submit documents electronically and receive products and return unused products)
Exclusion criteria 4.1.1 Prohibited Medications, Supplements or Herbal Products
Exclusionary
- Currently taking a probiotic, resistant starch, prebiotic or fiber supplement (or they
were taken within the last 14 days)
- Currently taking antibiotic, antiparasitic, or antifungal medications orally or
intravenously (or they were taken within the last 28 days)
- Initiation of/or changes to supplements or medications within 28 days prior to
screening
- Currently taking any supplements or medications impacting gastrointestinal motility
(e.g., SSRI's, PPI's, opioids) (one exception is use of PPI's if the PPI use is
stable, i.e., dosage and frequency is consistent, has not changed in the last month,
and will not change during the course of the study. Such individuals may be included
in the study at the discretion of the investigator)
- The use of any supplements or medications which influences digestion and absorption of
nutrients
4.1.2 Medical History and Concurrent Diseases Exclusions
- No serious, unstable illnesses including cardiovascular, hepatic, renal,
gastrointestinal, respiratory, endocrine, neurologic, immunologic, or hematologic
disease.
- Known infection with Human Immunodeficiency Virus (HIV), Tuberculosis or Hepatitis B
or C.
- Known intolerance or allergy to ingredients in test study product
- Active and severe gastrointestinal symptoms and/or infections
- The presence of any disease which influences digestion and absorption of nutrients
- History of any bariatric surgery procedure within the last 5 years
- History of gastrointestinal surgery within the last 5 years
- Currently have a colostomy or ileostomy bag in place
- Genito-urinary bacterial infections within the last 28 days
- Any cardiovascular disease including myocardial infarction, angina, cardiovascular
surgery, congestive heart failure, cardiac arrhythmias or conduction abnormalities,
cerebrovascular accident, transient ischemic attack (TIA), or peripheral vascular
disease, deep vein thrombosis or pulmonary embolus.
- Any personal history of pre-Diabetes, Diabetes Mellitus Type 1 or 2 or hypoglycemia.
- Personal history of seizure disorder other than a single childhood febrile seizure
that fully resolved.
- Any personal history of bipolar disorders, schizophrenia or psychotic behaviors.
- Any serious mental illness including depression, manic episodes, post-traumatic
disorder, obsessive-compulsive disorder, personality disorders, history of attempted
suicide or violence within 12 months prior to Screening and for the duration of the
study.
- A major medical or surgical event requiring hospitalization (for any reason other than
a scheduled medical procedure) within the preceding 3 months
- Malignancy within the last 5 years (with the exception of basal cell carcinoma,
squamous cell carcinoma, and/or carcinoma in situ of the cervix)
- Women who are lactating, pregnant or planning pregnancy within the next three months
4.1.3 Substance Use Exclusions
- Smoking or use of nicotine containing products 30 days prior to Screening and for the
duration of the study.
- History of alcohol abuse or a diagnosis of alcoholism within 12 months prior to
Screening and for the duration of the study.
- Consumption of alcohol (or more than 4 glasses within the last 2 weeks if considered
for the light alcohol use category, and no more than 2 glasses at once) for 14 days
prior to Screening.
- Use of drugs of abuse and recreational drugs/substances (such as but not limited to
opioids, cocaine, phencyclidine [PCP], and methamphetamine, including marijuana or
cannabinoids) within 12 months prior to Screening and for the duration of the study.
4.1.4 Other Exclusionary Criteria
- Inability to comply with study and/or follow-up visits.
- Any other concurrent condition which, in the opinion of the Investigator, would
preclude participation in this study or interfere with compliance.
- Initiation of or changes to an exercise regimen within 28 days prior to screening
- Initiation of or changes to a food plan within 28 days prior to screening
- Current involvement or within 28 days prior to screening of a significant diet or
weight loss program, such as NutriSystem, Jenny Craig, Atkin's or other low-carb diet
programs, or very low calorie liquid diet programs (such as Optifast, Medifast, and/or
HMR) or any diet that has led to a weight loss of 5% of body weight over a period of
10 weeks.
- Difficulty or aversion to taking powdered supplement
- Currently participating in another interventional research study or participated in
another interventional study within the previous 28 days
|
